Treatment of male urinary incontinence and sexual dysfunction

ABSTRACT

Methods and devices to diagnose and treat male urinary incontinence and sexual dysfunction are provided. A multiple sensor-enabled catheter for rectal insertion in a male patient allows for the visualization and manipulation or positioning of the bladder. A multiple sensor-enabled catheter for rectal insertion in a male patient allows for the visualization and implementation of efficient and effective exercises to strengthen pelvic floor muscles.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/580,708, filed Dec. 23, 2014, which is a continuation-in-partapplication of U.S. patent application Ser. No. 14/359,890, entitled“Treatment of Urinary Incontinence,” filed May 21, 2014, which claimspriority to international patent application PCT/US2012/066613, filedNov. 27, 2012, and U.S. provisional Patent Application No. 61/563,889,filed Nov. 28, 2011, the entirety of which are incorporated herein byreference for all purposes.

BACKGROUND

The present embodiments relate to the devices, diagnosis, and treatmentof male urinary incontinence and sexual dysfunction. The diagnosis andtreatment may involve the use of a multiple sensor-enabled cathetercapable of providing real-time data regarding the patient's anatomy andphysiology, such as muscular function of the pelvic floor and rectalsphincter, as well as the position and movement of the catheter withinthe patient.

Human males may experience urinary incontinence (UI), which is theunintentional loss (accidental leakage) of urine; as well as sexualdysfunction, which is a problem during the phase of the sexual responsecycle that prevents the man or couple from experiencing satisfactionfrom sexual activity. Reports indicate that urinary incontinence canoccur in 11% of the male population whereas male sexual dysfunction canoccur in 31% of the male population. Weak or damaged pelvic floormuscles (hypotonia), overactive pelvic floor muscles (hypertonia),certain prostate conditions, and nerve damage are some of the possibleunderlying causes of urinary incontinence in men. Different types ofurinary incontinence in men include stress incontinence, urgeincontinence, and overflow incontinence. Some men may experience morethan one type of incontinence. Diagnosis of urinary incontinence in mentypically involves a medical history and physical exam, and may includekeeping a bladder diary. Diagnosis may also include an ultrasound andurodynamic testing. Therapy for urinary incontinence in men may includebehavioral modification such as like bladder training and Kegelexercises, medication, surgery, or a combination of these therapies.

Sexual dysfunction is the inability to have satisfactory sexualactivity. This definition depends on each person's own interpretation ofsatisfactory sexual activity. Typically, male sexual dysfunctionincludes erectile dysfunction (ED, or impotence), and ejaculationproblems such as premature ejaculation. ED is the inability to acquireor maintain a satisfactory erection. The prevalence of erectiledysfunction varies according to the patient's age. About 18% of men from50 to 59 years of age and 37% of those aged 70 to 75 years will sufferfrom erectile dysfunction. Ejaculation problems involve the improperdischarge of sperm, prostatic, and seminal vesicle fluid through theurethra. Premature ejaculation is the most common of the ejaculatorydisorders; approximately 20% to 30% of men will have prematureejaculation. As with incontinence, sexual dysfunction in males is oftenassociated with, or caused by, pelvic floor dysfunction.

Pelvic floor muscle training (PFMT, or Kegel exercises), includes aseries of exercises designed to rehabilitate the musculature of thepelvic floor. For example, PFMT can help strengthen and tone the musclesunder the bladder, and bowel (large intestine), and thus aid those whohave problems with urine leakage, bowel control or sexual dysfunction. Acurrent problem with PFMT is that the individual is often unable tovisualize or attain the proper muscle position and control to carry outan efficient and effective exercise regimen required to rehabilitate thepelvic floor muscles.

SUMMARY

The embodiments described herein relate to the diagnosis and treatmentof male UI and male sexual dysfunction. In one embodiment, diagnosis andtreatment involves the use of a multiple sensor-enabled catheter capableof providing real-time data regarding the patient's anatomy andphysiology, such as muscular function of the rectal sphincter or pelvicfloor, as well as the position and movement of the catheter within thepatient. In one embodiment, the device may be a pressure sensor-enabledcatheter.

In one embodiment, the multiple sensor-enabled catheter may include atleast one sensor capable of providing real-time data of one or moretypes selected from the group consisting of position, movement,pressure, and flow. In this regard, a sensor may have a singlemeasurement and reporting capability, or may have multiple measurementand reporting capabilities.

The present embodiments also provide for methods for the diagnosis ortreatment of male UI, comprising positioning a multiple sensor-enabledcatheter in a male patient's rectum and determining the anatomical stateof the patient, which treatment is capable of relieving or amelioratingincontinence. The anatomical state may be the relative position of thebladder neck and urethra. The anatomical state may also be thesphincteric and supportive functions of the pelvic floor. The method ofdiagnosis or treatment may also include manipulating the patient torelieve the incontinence. The manipulation may be performed by thehealth care provider or the patient. The manipulation may includeachieving a particular anatomical position of the bladder neck relativeto the urethra or achieving a particular muscular function of the pelvicfloor.

The present embodiments also include a method for the diagnosis ortreatment of male sexual dysfunction, comprising positioning a multiplesensor-enabled catheter in a male patient's rectum and determining theanatomical state of the patient, which treatment is capable of relievingor ameliorating a sexual dysfunction. For example, the treatment ifcapable of achieving efficient and effective control of pelvic floormuscles to relieve the sexual dysfunction.

The present embodiments contemplate the real-time position and movementtracking as described in U.S. Pat. No. 8,805,472. In this regard, thereal-time position and movement tracking may include sensing theposition of the bladder relative to a fixed reference point within thepatient's body, by providing a catheter enabled with a sensor andcapable of providing positional or movement data. The fixed referencepoint within the body may be the pubic bone, the coccyx, the bladder,the urethra, the prostate, or the rectum. The method may be performed inreal-time, for example, during an operation. In another embodiment, themethod may be performed at multiple time intervals. The multiple timeintervals may occur, for example, pre- and post-event, wherein the eventmay be injury or surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a view of an example probe device comprising a multiplesensor-enabled catheter.

DETAILED DESCRIPTION

All patents, applications, and other publications identified areexpressly incorporated herein by reference for the purpose of describingand disclosing, for example, the devices methodologies described in suchpublications that might be used in connection with the presentinvention. These publications are provided solely for their disclosureprior to the filing date of the present application. Nothing in thisregard should be construed as an admission that the inventors are notentitled to antedate such disclosure by virtue of prior invention or forany other reason. All statements as to the date or representation as tothe contents of these documents are based on the information availableto the applicants and does not constitute any admission as to thecorrectness of the dates or contents of these documents.

As used herein and in the claims, the singular forms include the pluralreference and vice versa unless clearly indicated otherwise by context.Throughout this specification and claims, unless otherwise indicated,“comprise,” “comprises” and “comprising” are used inclusively ratherthan exclusively. The term “or” is inclusive unless modified, forexample, by “either.” Other than in the operating examples, or whereotherwise indicated, all numbers should be understood as modified in allinstances by the term “about.”

Unless otherwise defined, scientific and technical terms used hereinshall have the meanings that are commonly understood by those of skillin the art. The terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to limit the scope ofthe present invention, which is defined solely by the claims.

One embodiment described herein provides for methods for the diagnosisor treatment of male urinary incontinence, comprising positioning in therectum of a male patient a multiple sensor-enabled catheter, visualizingthe anatomical state of the patient, and manipulating the patient's bodyto a position capable of relieving the incontinence. In an additionalembodiment, the anatomical state is the relative position of one or moreinternal anatomical reference points selected from the pubic bone, thecoccyx, the bladder, the urethra, the prostate, and the rectum. In oneother embodiment, the anatomical state is the muscular function of thebladder or rectal sphincter.

Another embodiment described herein provides for methods for thediagnosis or treatment of male sexual dysfunction, comprisingpositioning in the rectum of a male patient a multiple sensor-enabledcatheter, visualizing the anatomical state of the patient, andmanipulating the patient's body to a position capable of strengtheningpelvic floor muscles. In an additional embodiment, the male sexualdysfunction is erectile dysfunction or premature ejaculation.

An additional embodiment provides for a method of rehabilitating thepelvic floor musculature, comprising positioning in the rectum of a malepatient a multiple sensor-enabled catheter and visualizing theanatomical state of the patient, wherein the patient manipulates thecatheter as a method of exercising control of sphincter or pelvic floormuscles.

In the present embodiments, for example, a catheter is enabled with atleast one sensor capable of providing real-time data of at least onedata type selected from the group consisting of position, movement,pressure, and flow. In this regard, a sensor may have a singlemeasurement and reporting capability, or may have multiple measurementand reporting capabilities. The data obtained by the multiplesensor-enabled catheter may be reported in any number of ways know inthe art, including the transmission to, and visualization on, agraphical user interface. For purposes of the embodiments, “real-time”may include instantaneous as well as delayed observation, reporting, orrecording of an event as it elapses.

Advantageously, by viewing a real-time image of where the bladder andurethra are located in a patient relative to one or more otheranatomical reference points during a procedure, a health care providermay manipulate the patient such that the patient's bladder and theurethra are in a position capable of relieving or amelioratingincontinence. In other instances, a patient himself may visualize hisown anatomical state using the multiple sensor-enabled catheter, and maymanipulate his body such that his bladder and the urethra are in aposition capable of relieving incontinence. Additionally, the patienthimself may visualize his anatomical state using the multiplesensor-enabled catheter, and may manipulate his body to a positioncapable of controlling his pelvic floor muscles to relieve incontinence.

In addition, by viewing a real-time image of where the bladder andurethra are located in a patient relative to one or more otheranatomical reference points during a procedure, a health care providermay manipulate the patient such that the patient is in a positioncapable of strengthening his pelvic floor muscles. In other instances,the patient himself may visualize his anatomical state using themultiple sensor-enabled catheter, and may manipulate his body to aposition capable of strengthening his pelvic floor muscles. In eitherinstance, the visualization allows the health care provider or the malepatient to achieve the efficient and effective exercising of his pelvicfloor muscles to control pelvic floor musculature and relieve sexualdysfunction.

A multiple sensor-enabled catheter provides a valuable study ordiagnostic tool for a health care provider as well as a patient,particularly when the patient is considering surgery that may result inUI or sexual dysfunction as a side effect or post-surgical complication.For example, a health care provider may provide the patient with anin-office procedure that determines a baseline position or relativemobilization of the bladder (baseline), before possible damage to hispelvic floor that might occur, for example, during prostate orcolorectal surgery; such that if surgical repair is subsequentlyperformed, his bladder can be repositioned to the original,pre-incontinence anatomic position. Surgery could also be performed onpatients with a surgically correctable structural defect, using themultiple sensor-enabled catheter to provide positioning data. Suchprocedures may involve a male sling, placement of an artificial bladdersphincter, bulking, or ultimately urinary diversion.

A multiple sensor-enabled catheter can also be used as a diagnostic toolwhere the position of the bladder needs to be adjusted surgically tocorrect a urinary problem, such as that involving male prostactichypertrophy causing a stricture of the urethra. The multiplesensor-enabled catheter may also be used after male prostatectomy tohelp determine the optimal positioning of the urethra and bladder neck,or the pressure exerted by the bladder sphincter. Another use for amultiple sensor-enabled catheter would be to correct male fecalincontinence

The multiple sensor-enabled catheter may incorporate at least one sensorcapable of measuring or reporting data of various types, includingposition, movement, pressure, or flow. A multiple sensor-enabledcatheter with more than one individual sensor may be arrayed as depictedin FIG. 1, or it may incorporate a single sensor that has multiplemeasurement and reporting capabilities.

The position or movement data may be of the sort measured or reported byany number of sensor devices, including accelerometer, gyroscope,inductive non-contact position sensor, string potentiometer, linearvariable differential transformer, potentiometer, capacitive transducer,Eddy-current sensor, Hall effect sensor, optical proximity sensor,piezo-electric transducer, or photodiode array sensor devices. Theposition or movement data may also include magnetic, electromagnetic,microelectromechanical, radio frequency, ultrasound, or video data.

The pressure or flow data may be of the sort measured or reported by anynumber of sensor devices, including force collector types, such aspiezo-resistive, capacitive, electromagnetic, piezo-electric, optical,potentiometric, or other types, such as resonant, thermal, ionization,ultrasonic, or density (mass and index of refraction) sensor devices.

For example, an embodiment of a multiple sensor enabled cathetercomprising a firm tip, which may be about ½ inch in length to guide thecatheter through the rectum. The number and precise placement of anindividual sensor may vary depending on the type of positional,movement, pressure or flow measurement or reporting system employed. Anindividual sensor may have a single function or be multifunction (suchas positional tracking combined with pressure and flow sensing). Themultiple sensor-enabled catheter may also embody a video observation orrecording device as well as an illumination source to facilitate suchvideo capture. The precise placement of the sensor(s) and video capturecomponent(s) are not pre-defined, and may be configured according to therequirements of the desired application.

EXAMPLES

As described herein, catheters useful in the present embodiments mayembody at least one sensor capable of measuring and reporting at leastone data type, including position, movement, pressure, and flow. Theseinclude, but are not limited to, magnetic, electromagnetic,microelectromechanical, radio frequency, ultrasound, and video. Oneexample of a multiple sensor-enabled catheter, as shown in FIG. 1, is aprobe or catheter 100 containing multiple sensors arranged in an array102. The probe or catheter 100 may be constructed of a silicon or othermaterial suitable for medical use in or on a patient's body. The probeor catheter 100 may include a distal probe or catheter tip 101, whichmay be constructed of a material with sufficient hardness or rigidity tofacilitate the ease of insertion of the probe or catheter 100 into apatient's rectum. The probe or catheter 100 may also contain a proximalportion with a connector/handle 104 to facilitate positioning ormovement of the probe or catheter 100 by the patient or health careprovider. A sensor, such as a pressure sensor 103, may be contained inthe proximal portion of the probe or catheter 100 to facilitate theassessment of rectal sphincter strength and/or control when the probe orcatheter 100 is inserted into the patient's rectum.

In other embodiments, the sensor(s) may be positioned in the probe orcatheter 100 without a particular spatial relationship to any othersensor(s). The probe or catheter 100 may contain amicroelectromechanical (MEMS) device(s), a 3-axis accelerometer, aroll/pitch gyroscope and a yaw rate gyroscope, and a pressure and flowtransducer. The devices may also be mounted on a small flexible printedcircuit board (PCB) and then attached to the probe or catheter. The3-axis accelerometer may track translation of the probe or catheter inthree directions. The gyroscopes are utilized to account forgravitational rotation, allowing real-time movement to be tracked.

In one embodiment, a PCB may be prepared with the three MEMS devicesmounted thereon. Soft leads trail the MEMS devices to supportingdevices, including, for example, a data acquisition card which may beused for transforming analog signals to digital signals. The PCB is setwithin the wall of the probe or catheter. The location of the probe orcatheter may be determined by the output signals of the MEMS devices.

The multiple sensor enabled catheter may be linked via data cable 105 toa transmitter 106, which can provide a wireless data signal (such asBluetooth) to a device 107 (computer, tablet, smartphone, or similardevice) capable of receiving the transmission of data collected by thesensors. The connection of the data cable 105 to the catheter or probe100 may be achieved through a mating interface with connector/handle104. Alternatively, the transmitter may be contained within theprobe/catheter or the probe/catheter handle. The linked device 107 mayprocess the data or provide a graphical user display, or transmit suchinformation to another device(s) to accomplish similar tasks. In anotherembodiment, the probe or catheter 100 may transmit a wireless datasignal directly to the device 107.

The patient may be asked to recreate maneuvers that induce incontinenceat the same time that the parameters for thelocation/pressure/flow/visualization of the urethra and bladder aredetermined.

The urethra and bladder are manipulated to the position where muscularpressure is optimized and urine flow is returned to normal physiologicalcontrol. These positions for the urethra and bladder neck may bedisplayed in real-time on a graphical user interface and/or recorded.

In the case of surgical intervention, if no pre-incontinence position isknown, the urethra and bladder neck are positioned based on datacollected from a cohort of patients with similar UI history or profile.Where pre-incontinence data is available (e.g., the positions of theurethra and bladder neck are based on patient information from anearlier date), then at the time of surgery the urethra and bladder neckare repositioned to the location where the patient was previouslydetermined to be continent.

Following examination using the multiple sensor-enabled catheter, ahealth care provider may conclude that rehabilitation is an efficaciousoption for the patient. In this regard, the measurements provided by themultiple sensor-enabled catheter may be recorded to facilitateappropriate patient instructions on performing Kegel exercises in anoptimal manner using the visual (on-screen) information provided by thecatheter in real-time. Once engaging the proper musculature has beensuccessfully communicated to a patient during a medical office visit,the patient may be sent home with the instructions to perform Kegelexercises five to six times daily, for example. Four to six weeks laterthe patient may return for another examination using the multiplesensor-enabled catheter to evaluate rehabilitative treatmenteffectiveness, which may allow a health care provider to advise thepatient about the prospects for restoring complete continence oralleviating sexual dysfunction with a continued rehabilitation regime ora surgical procedure.

Detailed embodiments are disclosed herein; however, it is to beunderstood that the disclosed embodiments are merely exemplary of theclaimed invention that may be embodied in various forms. It will beappreciated that many modifications and other variations that will beappreciated by those skilled in the art are within the intended scope ofthis invention as claimed below without departing from the teachings,spirit, and intended scope of the invention.

What is claimed is:
 1. A method for the diagnosis or treatment of maleurinary incontinence comprising inserting into the rectum of a malepatient a multiple sensor-enable catheter, visualizing the anatomicalstate of the patient, and manipulating the patient's body to a positioncapable of relieving the incontinence.
 2. The method of claim 1, whereinthe anatomical state is the relative position of one or more patientanatomical reference points selected from the group consisting of thepubic bone, the coccyx, the bladder, the urethra, the prostate, and therectum.
 3. The method of claim 1, wherein the anatomical state is themuscular function of the bladder sphincter.
 4. The method of claim 1,wherein the anatomical state is the muscular function of the rectalsphincter.
 5. The method of claim 1, wherein the anatomical state is themuscular function of the pelvic floor.
 6. The method of claim 5, whereinthe manipulating is done by the patient.
 7. A method for the diagnosisor treatment of male sexual dysfunction comprising inserting into therectum of a male patient a multiple sensor-enable catheter, visualizingthe anatomical state of the patient, and manipulating the patient's bodyto a position capable of strengthening pelvic floor muscles.
 8. Themethod of claim 7, wherein said dysfunction is erectile dysfunction. 9.The method of claim 7, wherein said dysfunction is prematureejaculation.
 10. The method of claim 7, wherein the manipulating is doneby the patient.